Skelaxin
Approved
Approval ID
cb28abf4-608f-4dcb-b179-9dcf71274dbb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 21, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Metaxalone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4733
Application NumberNDA013217
Product Classification
M
Marketing Category
C73594
G
Generic Name
Metaxalone
Product Specifications
Route of AdministrationORAL
Effective DateJuly 21, 2010
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
METAXALONEActive
Quantity: 800 mg in 1 1
Code: 1NMA9J598Y
Classification: ACTIB
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CALCIUMInactive
Code: SY7Q814VUP
Classification: IACT